Phase 3
N=50
The Effect of N115 on Coughing in IPF Patients
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT06037408 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Percent Change in Coughing Episodes Per Day From Baseline to Day 21. — -73.2; -16.1 % change in coughing episodes — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 20mM sodium pyruvate nasal spray (Drug); Saline Placebo control nasal spray (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Cellular Sciences, inc.
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Coughing Episodes Per Day From Baseline to Day 21. |
-73.2; -16.1 | 0.0001 sig |
| SECONDARY Percent Change in FEV1/FVC Ratios From Baseline to Day 21. |
27.9; 2.73 | <0.0001 sig |
Summary
The purpose of this clinical trial is to administer a sodium pyruvate nasal spray that eliminates nasal oxidative stresses, caused by oxygen radicals, and demonstrate the efficacy of sodium pyruvate to reduce coughing and increase lung functions in patients with idiopathic pulmonary fibrosis. This will be a 21-day double-blinded randomized placebo-controlled trial designed to determine if patients with idiopathic pulmonary fibrosis treated with 20mM sodium pyruvate in 0.9% sodium chloride nasal spray solution will have reduced chronic coughing, as well as increased lung function (FEV1, FVC endpoints of 12% or more within the first week) and improved FEV1/FVC ratios.
Eligibility Criteria
Inclusion Criteria
- Individuals with a clinical diagnosis of idiopathic pulmonary fibrosis in accordance with the most recent collaborative guidelines from the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Association including HRCT scan and/or lung biopsy consistent with unusual interstitial pneumonia (UIP), especially honeycombing, without identifiable cause related to other ILD such as drug toxicity, occupational or environmental exposure or connective tissue disease.
- condition-related cough.
- Mild to moderate FEV1 and FVC at 50% or greater of standard
- Individuals who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent contraception, during the entire course of the study.
Exclusion Criteria
- Pulmonary disease other than idiopathic pulmonary fibrosis.
- Respiratory infections in the last 2 weeks.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina.
- Pregnancy (urine pregnancy test will be performed prior to enrollment).
- Females of childbearing potential age not on adequate contraception or lactating females.
- Subjects less than 18 years of age.
- Hospitalization within last 6 months due to acute exacerbation of airway disease.
- Subjects with a clinically significant abnormal chest X-ray within past 12 months.
- Medication changes within 1 month of study entry except for antiviral, antibiotic, or antimicrobial medications as well as corticosteroids, antihistamines, or anti-inflammatory medications.
- Subjects who have participated in another drug treatment study within the last month.
- Subjects with a current history of alcohol or recreational drug abuse.
- Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.
- Subjects with metabolic diseases (diabetes, hypoglycemia, etc.).
Data sourced from ClinicalTrials.gov (NCT06037408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.